VASER ASPIRATING CANNULA
Received Jun 16, 2022
Report 3011423170-2022-00078 · MDR key 14718539
Device
Generic name
System, Suction, Lipoplasty For Removal
Manufacturer
Solta Medical, IncModel number
810GHBU3726VXNRLot number
222
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE PRODUCT HAS BEEN RETURNED AND WILL BE EVALUATED SHORTLY. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
A USER FACILITY REPORTED THAT DURING TREATMENT WITH A VASERLIPO SYSTEM THEY HAD A CANNULA BREAK LEADING TO A DELAY IN SURGERY OF 20 MINUTES WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE CANNULA DID NOT BREAK WHILE INSIDE OF THE PATIENT. THERE WAS NO PATIENT IMPACT.
Additional Manufacturer Narrative
THE CANNULA WAS RETURNED FOR EVALUATION. SERVICE WAS ABLE TO CONFIRM THAT THE CANNULA WAS BROKEN AT THE BASE. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. COMPLAINT TYPE IDENTIFIED WITHIN RISK ANALYSIS AND PERFORMING WITHIN ANTICIPATED RATE. NO CORRECTIVE ACTION IS REQUIRED.
Additional Manufacturer Narrative
CORRECTION: REVISED H6 INVESTIGATION CONCLUSIONS CODE FROM 4307 TO 4315 CORRECTION TO H11 NARRATIVE: CONFIRMED DAMAGED CANNULA. CANNULA APPEARED TO BE SEPARATED FROM THE HUB. THERE WERE NO OBVIOUS SIGN OF BOND DEGRADATION FROM A CHEMICAL SOLUTION BETWEEN THE LUMAN AND HUB THAT MIGHT HAVE BEEN USED DURING CLEANING PROCESS. EVALUATION FOUND THE DIMENSIONS OF THE CANNULA WERE WITHIN THE PRODUCT DESIGN. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSIONS CAN BE FOUND.